The Definitive, Flexlens, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The Definitive, Flexlens, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.

The Definitive, Flexlens, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eves and/or possesses refractive astigmatism not exceeding . 75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The Definitive, Flextens, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The Definitive, Flexlens, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

Device Description

The Definitive, Flexlens Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A. which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

AI/ML Overview

Acceptance Criteria and Study Findings for Definitive, Flexlens - Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)

This document describes the acceptance criteria and the study that demonstrated the Definitive, Flexlens - Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) meets these criteria, based on the provided 510(k) summary (K100443).

1. Table of Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are primarily established by its substantial equivalence to predicate devices, meaning its physical properties, intended use, and safety/effectiveness are comparable. The study did not define explicit numerical acceptance criteria for clinical performance but focused on demonstrating equivalence.

Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Definitive, Flexlens - efrofilcon A)
Material	Silicone Hydrogel (efrofilcon A)	Same as predicate: efrofilcon A
Production Method	Lathe-Cut, custom manufactured	Same as predicate: Lathe-Cut, custom manufactured
Intended Use	Daily wear for correction of ametropia (myopia/hyperopia) in aphakic/non-aphakic persons with non-diseased eyes; also for irregular corneal conditions (keratoconus, post-graft fitting)	Same as predicate: Daily wear for correction of ametropia (myopia/hyperopia) in aphakic/non-aphakic persons with non-diseased eyes. Includes spherical, toric, multifocal, multifocal toric, and irregular cornea configurations. Indicated for management of irregular corneal conditions.
Functionality	Act as a refractive medium to focus light on the retina.	Same as predicate: Acts as a refractive medium that focus light rays from near and distant objects on the retina.
Water Content	74% (matching "IntelliWave" and "ActiFresh 400" predicates)	74%
Oxygen Permeability	Approx. 60 x 10^-11 (cm²/sec) (ml O₂/ml x hPa @ 35°C), (revised Fatt method) (matching "IntelliWave" predicate)	59.8 x 10^-11 (cm²/sec) (ml O₂/ml x hPa @ 35°C), (revised Fatt method). (Stated as 60 x 10^-11 in comparative table)
Refractive Index	1.38	1.38
Light Transmission	Greater than 97%	Greater than 97%
Surface Character	Hydrophilic	Hydrophilic
Specific Gravity	1.048 (hydrated) (Note: table shows 1.139 for both new device and IntelliWave - possible discrepancy or different measurement. Using 1.048 from description)	1.048 (hydrated)
Biocompatibility	Non-toxic and non-irritating to ocular tissue.	Non-clinical toxicology and biocompatibility tests performed according to GLP regulations; results demonstrate packaging material and extracts are not toxic and not irritating.
Sterility	Sterile for the indicated shelf-life.	Non-clinical testing demonstrates lenses are sterile for the indicated shelf-life.
Shelf-Life Stability	Consistent product stability and packaging integrity for stated shelf-life.	Non-clinical testing validating product stability, package integrity, and sterilization process.
Clinical Performance	Clinical performance equivalent to predicate devices.	Clinical performance of the efrofilcon A lens material previously established (not required for this 510(k)). The device is identical to cleared "Intelliwave³ (efrofilcon A)" (K100221).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable for clinical testing of the current device. The document explicitly states: "The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k)." The current submission relies on the established performance of the material (efrofilcon A) which is part of the predicate device "Intelliwave³ (efrofilcon A)" (K100221).
Data Provenance: Not specified for the historical clinical data related to the efrofilcon A material. However, all non-clinical toxicity and biocompatibility tests for the current device were conducted in accordance with GLP (Good Laboratory Practice) regulations, implying controlled laboratory settings rather than human subject testing in the context of this specific 510(k). The non-clinical data is prospective as it was specifically performed for this submission. The country of origin is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. No new clinical studies were conducted for this 510(k) submission, and therefore no "experts" were used to establish a ground truth for a test set in the context of a new clinical evaluation. The ground truth for safety and effectiveness is established by the previous clearance of the predicate device (Intelliwave³ efrofilcon A) and the inherent properties of the efrofilcon A material.

4. Adjudication Method for the Test Set

Not applicable. No new clinical test set requiring adjudication was used in this 510(k) submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This was not a diagnostic device involving a multi-reader multi-case (MRMC) study. The device is a contact lens, and its effectiveness is determined by its physical properties, biocompatibility, and functional equivalence to legally marketed predicate devices.

6. Standalone Performance Study

A standalone performance study for the clinical effectiveness of the algorithm (device) was not explicitly conducted as part of this 510(k) submission. The submission relies on the established clinical performance of the efrofilcon A lens material from prior clearances.

However, various non-clinical (in vitro and in vivo preclinical toxicology and biocompatibility) tests were performed on the Definitive, Flexlens device in a standalone manner to assess its safety. These tests assessed:

Sterility
Packaging material and extract toxicity/irritation
Lens physical and material properties

7. Type of Ground Truth Used

The "ground truth" for the device's safety and effectiveness in this 510(k) is based on:

Substantial Equivalence: The primary ground truth is the established safety and effectiveness of the predicate devices, particularly the "IntelliWave', Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)" (K100221), to which the new device is stated to be identical in material and manufacturing process.
Non-clinical Testing: Laboratory testing (toxicology, biocompatibility, sterility, shelf-life) performed according to GLP regulations and valid scientific protocols provided ground truth for these specific safety aspects.
Previously Established Clinical Performance: The document states, "The clinical performance of the (efrofilcon A) lens material has been previously established," indicating reliance on prior clinical data for the material itself.

8. Sample Size for the Training Set

Not applicable. This device is a medical device (contact lens), not an AI/ML algorithm that requires a "training set" in the computational sense. The manufacturing process does not involve machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

Summary

{0}------------------------------------------------

PAGE 1 OF 6

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS 2 8 200

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

. .

The assigned 510(k) number is:	K100443
Applicant information:
Date Prepared:	September 24, 2010
Name:	X-CEL CONTACTS, A Walman Optical Company
Address	2775 Premiere Pkwy, Suite 600 Duluth, GA 30097
Contact Person:	Robert Chambers Official Correspondent Director of Operations
Phone number:	(770) 622-9235
Consultant:	Martin Dalsing Medvice Consulting, Inc. 806 Kimball Avenue Grand Junction, CO 81501
Phone number	(970) 243-5490
Device Information:
Device Classification:	Class II
Classification Number:	LPL
Classification Name:	Lenses, Soft Contact, Daily Wear
Trade Name:	Definitive, Flexlens - Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)

{1}------------------------------------------------

100443 AGE 2 OF

Equivalent Devices:

The Definitive, Flexlens Silicone Hydrogel Daily Wear Soft Contact Lenses (efrofilcon A) are substantially equivalent to the following predicate devices:

Predicate devices:

"IntelliWave', Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)" by Art Optical Contact Lens, Inc. 510(k) number: K100221

"Flexlens Multifocal (hioxifilcon B)" by X-Cel Contacts. 510(k) number: K070308

"Biofinity (comfilcon A)" by Coopervision, Inc. 510(k) number; K052560

"ActiFresh 400 (lidofilcon A)" By Hydron Ltd. 510(k) number: K983637

Device Description:

{2}------------------------------------------------

The Physical properties of the lens are:

Refractive Index	1.38
Light Transmission	greater than 97%
Surface Character	hydrophilic
Water Content	74 %
Specific Gravity	1.048 (hydrated)
Oxygen Permeability	59.8 x 10-11 (cm2/sec) (ml O₂/ml x hPa @ 35°C), (revised Fatt method).

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 74% water by weight. The lenses will be manufactured in spherical, toric, multifocal, multifocal toric and irregular Cornea configurations with the following features and properties.

• Chord Diameter	12.0 mm to 16.00 mm
• Center Thickness	0.01 mm to 0.50 mm
• Base Curve	8.0 mm to 9.5 mm
• Power Range	-20.00D to +20.00D in 0.25 steps
• Cylinder Power (Toric)	-0.25D to -12.00D
• Cylinder Power (Multifocal Toric)	-0.25D to -4.00D
• Add Power (Multifocal)	+0.50D to +4.00D

The lens is supplied sterile in vials containing a buffered saline solution. Vial labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

Intended Use:

The Definitive, Flexlens, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding. 75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

{3}------------------------------------------------

K100443
PAGE 4 OF 6

The Definitive, Flexlens, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning. disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

Testing:

Non-clinical Testing	A series of in vitro and in vivo preclinical toxicology and biocompatibility tests wereperformed to assess the safety and effectiveness of the Definitive, Flexlens, (efrofilconA) Silicone Hydrogel Soft Contact Lenses packaged in glass vials. All non-clinicaltoxicology tests were conducted in accordance with the GLP regulation. All othertesting was conducted according to valid scientific protocols.
	Test results of the non-clinical testing on the Definitive, Flexlens, (efrofilcon A)Silicone Hydrogel Soft Contact Lenses demonstrate that:
	Lenses supplied in glass vials are sterile for the indicated shelf-life,The packaging material and extracts are not toxic and not irritating, andLens physical and material properties are consistent with currently marketed lenses.
Clinical Data	The clinical performance of the (efrofilcon A) lens material has been previouslyestablished, and therefore was not required for this 510(k).
	The Definitive, Flexlens, (efrofilcon A) Silicone Hydrogel Daily Wear Soft ContactLens is identical to the cleared Intelliwave3 (efrofilcon A) Silicone Hydrogel DailyWear Soft Contact Lens, cleared under K100221.
	The Definitive, Flexlens, (efrofilcon A) Silicone Hydrogel Daily Wear Soft ContactLenses have the identical manufacturing process (lathe-cut versus lathe-cut) as themarketed Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens,cleared under K100221.

{4}------------------------------------------------

Substantial Equivalence:

The following matrix illustrates the production method, lens function and material characteristics of the Definitive, Flexlens, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, as well as the predicate devices.

Conclusions Drawn from Studies

Validity of Scientific Data

Several laboratories under Good Laboratory Practice regulations conducted toxicology studies, Microbiology, chemistry, shelf-life stability studies and followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7

Substantial Equivalence

Information presented in this Premarket Notification establishes that the Definitive, Flexlens, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the requested indication.

Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of Silicone Hydrogel, Daily Wear Soft Contact Lens. The benefits to the patient are the same as those for other Silicone Hydrogel contact lenses.

{5}------------------------------------------------

	Definitive - Flexlens Silicone Hydrogel (efrofilcon A) New Device	IntelliWave³, Silicone Hydrogel (efrofilcon A) predicate device	Flexlens Multifocal (hioxifilcon B) predicate device	CooperVision Biofinity (comfilcon A) predicate device	Hydron Ltd. ActiFresh 400 (lidofilcon A) predicate device
Intended Use	Indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may also be prescribed for management of irregular corneal conditions such as keratoconus and post graft fitting	Indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may also be prescribed for management of irregular corneal conditions such as keratoconus and post graft fitting.	Indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia, posses refractive astigmatism and/or are Presbyopic	Indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia.	Indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia
Functionality	same as predicate device	The contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina.	The contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina	The contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina.	The contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina.
Indications	Daily wear, Silicone Hydrogel Soft (hydrophilic) contact lens	Daily wear, Silicone Hydrogel Soft (hydrophilic) contact lens	Daily wear, Soft (hydrophilic) contact lens	Daily wear, Silicone Hydrogel Soft (hydrophilic) contact lens	Daily wear, Soft (hydrophilic) contact lens
Production Method	Lathe-Cut, custom manufactured	Lathe-Cut, custom manufactured	Lathe-Cut, custom manufactured	Cast Molded, mass produced	Lathe-Cut, custom manufactured
USAN name	efrofilcon A	efrofilcon A	hioxifilcon B	comfilcon A	lidofilcon A
Water Content	74%	74%	49%	48.0%	74.0%
Oxygen Permeability	$60 x 10^{-11} (cm^2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$	$60 x 10^{-11} (cm^2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$	$15 x 10^{-11} (cm^2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$	$128 x 10^{-11} (cm^2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$	$28 x 10^{-11} (cm^2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method)$
Specific Gravity	1.139	1.139	1.142	1.142	1.060

KI00443
PAGE 6 of 6

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three distinct lines forming its body and wings. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the upper portion of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

X-Cel Contacts c/o Medvice Consulting, Inc. Mr. Martin Dalsing Official Correspondent 806 Kimball Avenue Grand Junction, CO 81501

OCT 2 8 2010

Re: K100443

Trade/Device Name: Definitive Flexlens Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: September 24, 2010 Received: September 27, 2010

Dear Mr. Dalsing:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{7}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Debmal Falls

Malyina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

Definitive, Flexlens Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) Device Name:

INDICATIONS FOR USE:

The Definitive, FlexIens, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The Definitive, FlexIens, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eves and/or possesses refractive astigmatism not exceeding . 75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

Evecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✔ (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Over-The-Counter Use

Over-The-Counter Use
Marc Polloy

(Division Sign-Off) Division of Ophthalmic. Neurological and Ear, Nose and Throat Devices

510(k) Number K100443

Regulation Number and Section

§ 886.5925 Soft (hydrophilic) contact lens.

(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.